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Clinical Trials/NCT06042439
NCT06042439RecruitingNot Applicable

Effects of AM vs. PM Exercise Training on Blood Pressure and Vascular Health in Postmenopausal Females With Hypertension

Michigan State University2 sites in 1 country79 target enrollmentStarted: June 11, 2024Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
79
Locations
2
Primary Endpoint
Nocturnal systolic blood pressure (BP)

Study Overview

Brief Summary

The treatment of high blood pressure, or hypertension, is multifaceted and can include pharmacological therapies (i.e., medications) and lifestyle modifications such as physical activity. Chronotherapy, which describes timing of a treatment with the body's daily rhythms, has recently been used with hypertension medications and has been shown to be effective at lowering blood pressure and reducing the risk of cardiovascular disease events. Specifically, taking medications in the evening was shown to be more effective than morning medication routines. Little information is available about the effectiveness of chronotherapy combined with exercise (i.e., planned physical activity) interventions in older adults with hypertension. The purpose of this study is to examine how exercise training performed in the morning and early evening affects blood pressure and other measures of blood vessel health in postmenopausal females with hypertension.

Detailed Description

Blood pressure has an internal rhythm associated with the 24-hr clock. Nocturnal blood pressure (BP) is a key contributor to cardiovascular health and may be improved by exercise. Moreover, the time of day of the exercise may be a key factor. This study aims to evaluate the effects of morning and evening exercise training on BP and other measures of vascular function in older females with hypertension.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
55 Years to 80 Years (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Systolic BP equal to or greater than 130 mmHg without BP medication or greater than 120 mmHg with medication and diastolic blood pressure equal to and greater than 80 mmHg
  • 55-80 years old
  • Post-menopausal female
  • Able to walk without assistance

Exclusion Criteria

  • Habitually physically active defined as 150 minutes of moderate-intensity or 75 minutes of vigorous-intensity aerobic physical activity per week
  • Overt pulmonary disease/condition as follows: chronic bronchitis, chronic obstructive pulmonary disease, emphysema, or pulmonary hypertension
  • Cardiometabolic disease/condition as follows: diabetes, heart failure, peripheral arterial disease, stroke, coronary artery disease, renal disease, secondary hypertension, chronic venous insufficiency or deep vein thrombosis within last 6 months
  • Cancer within last 5 years
  • Body mass index >39 kg/m2
  • Current smoking or vape
  • Evening shift work
  • uncontrolled thyroid disorder
  • 2 or more falls in the last year
  • Anemia within 3 months of enrollment
  • Parkinson's disease
  • Unstable angina
  • Acute pulmonary embolus or infarction
  • Acute myocarditis or pericarditis
  • Acute aortic dissection

Outcomes

Primary Outcomes

Nocturnal systolic blood pressure (BP)

Time Frame: 6 weeks

Change in systolic nocturnal BP (Pre-training - Post-training)

Secondary Outcomes

  • Endothelial function(6 weeks)
  • Microvascular function(6 weeks)
  • Ambulatory blood pressure(6 weeks)
  • Arterial stiffness(6 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Katharine Currie

Assistant Professor

Michigan State University

Study Sites (2)

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